Combined Effect of LIMICOL and Physical Activity on LDL Cholesterol and Muscle Function.

NCT05750602 | Completed

• 1 other identifier: 2013-A00061-44
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

Cardiovascular disease (CVD), foremost among which ischemic heart disease and stroke, are the leading cause of mortality and morbidity in France. These diseases are multifactorial origin and even if it is not possible to act on risk markers such as age, sex, or heredity, risk factors like high cholesterol, smoking , hypertension, obesity, diabetes and physical inactivity, are the main target of prevention strategies. Dydlipidemias have a role in the formation of CVD in participating in the genesis of atherosclerosis. The cholesterol and LDL-cholesterol in particular is subject to oxidation process in plasma. The molecules of oxidized LDL-cholesterol, small and dense, easily penetrate the arterial endothelial wall and are greeted by macrophages. Following a succession of different processes including inflammation, atherosclerotic plaque is formed. The result is either an arteriopathy when the arterial lumen narrowing, or atherothrombosis in the event of plaque rupture. Given this pathophysiology, reduce blood lipids, including LDL-cholesterol and reducing oxidation and inflammation are interesting strategies in the context of cardiovascular prevention. Several scientific study showed that nutritional supplementation with some plant extracts such as artichokes, garlic, red yeast rice, or the sugar cane policosanol helps to reduce several cardiovascular risk factors including regulate concentrations of circulating lipids. In this study, we hypothesize that the food supplement LIMICOL contributes to reducing LDL cholesterol in the context of care for patients (dietary measures and physical activity)

Conditions

Hypercholesterolemia

Keywords

Hypercholesterolemia; LDL cholesterol

Outcome Measures

Primary Outcomes (1)

• LDL-cholesterol levels (g/l) at the end of study

  Effect of LIMICOL supplementation showed by ANCOVA analysis of LDL cholesterol (g/l), with baseline LDL as covariable

  Week 12

Secondary Outcomes (27)

• Muscle function on tissue biopsy

  Week 0; Week 12

• Total cholesterol

  Week 0; Week 6; Week 12

• HDL-cholesterol

  Week 0; Week 6; Week 12

• Triglycerides

  Week 0; Week 6; Week 12

• LDLox

  Week 0; Week 6; Week 12

Study Arms (2)

LIMICOL

EXPERIMENTAL

LIMICOL : red yeast rice (with monacolin K, 2 mg), artichoke leaf extract, policosanols, French maritime Pine bark extract, Garlic extract, vitamins E, B2 and B3. 1 tablet during the 3 principal meals for 12 weeks.

Dietary Supplement: LIMICOL

PLACEBO

PLACEBO COMPARATOR

dicalcium phosphate, calcium citrate, vegetable magnesium stearate, microcrystalline cellulose, Maltodextrin, Tricalcium phosphate, Beet powder, Yellow coloring shellac, Brown coloring shellac. 1 tablet during the 3 principal meals for 12 weeks.

Dietary Supplement: PLACEBO

Interventions

LIMICOL DIETARY_SUPPLEMENT

Suplementation with LIMICOL, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.

LIMICOL

PLACEBO DIETARY_SUPPLEMENT

Suplementation with PLACEBO, 3 tablets per day, together with supervised physical activity (3 times per week) for 12 weeks.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI between 25 and 35 kg/m²
• Subject has a stable weight for at least three months before the start of the study.
• LDL ≥ 1.50 g/L
• g/L ≤ triglycerides ≤ 4.00 g/L
• Subject able and willing to comply with the protocol and agreeing to give his informed consent in writing;
• Subject affiliated with a social security scheme

You may not qualify if:

• Subject having a confirmed or suspected food allergy, notably to one of the components of the study product;
• Subject suffering from a severe chronic condition deemed incompatible with participation in the study by the investigator
• Subject with glaucoma
• Subject with uretroprostatic disorder
• Subjet anxious (score \>9 HAD scale)
• Subject with diabetes
• Subjet with treatment anticoagulant

Sponsors & Collaborators

• Lescuyer Laboratory: lead
• Hopital Gabriel Montpied: collaborator
• Centre de Recherche en Nutrition Humaine d'Auvergne: collaborator
• Clinique Médicale Cardio-Pneumologie de Durtol: collaborator
• Université d'Auvergne: collaborator

Study Sites (4)

Clermont Université, Université Blaise Pascal, EA 3533, Laboratoire des Adaptations Métaboliques à l'Exercice en Conditions Physiologiques et Pathologiques (AME2P), BP 10448

Clermont-Ferrand, F-63000, France

Location

CRNH-Auvergne

Clermont-Ferrand, F-63001, France

Location

Service de médecine du sport et des explorations fonctionnelles, CHU G. Montpied

Clermont-Ferrand, F-63003, France

Location

Clinique de cardiopneumologie de DURTOL

Durtol, F-63830, France

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Martine Duclos, Pr

  CHU G. Montpied

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: March 1, 2023
• Study Start: November 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2018
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

FR (4)